HeartWare HVAD System
FDA premarket approval P100047/S196 · decided 2022-09-30
Approval details
- PMA number
- P100047
- Supplement
- S196
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2022-04-07
- Decision date
- 2022-09-30
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a modification to the HVAD Battery configuration mode and changes to the Battery Pack Final Tester software
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| CD Horizon Spinal System (K223494) | Medtronic | 2023-01-23 |
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| Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system (K222873) | Medtronic | 2022-11-07 |
| CD Horizon™ Spinal System (K221244) | Medtronic | 2022-05-25 |